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Find Clinical Drug Pipeline Developments & Deals by CytoDyn

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            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Vyrologix

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 22, 2021

            Details:

            CD12 COVID-19 trial data has been unblinded and the results will be reported when the Company has concluded its ongoing discussions with regulators. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5.

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            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Vyrologix

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 15, 2020

            Details:

            CytoDyn had reached full enrollment in its Phase 3 registrational trial for patients with severe-to-critical COVID-19. The 390-patient data will be analyzed in approximately 28 days, with expected results to be announced shortly thereafter.

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            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: Vyrologix

            Highest Development Status: Phase II/ Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: amfAR

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership November 23, 2020

            Details:

            The Partnership aims at testing the ability of Vyrologix (leronlimab) to mediate a functional HIV cure. Recently, Vyrologix (leronlimab) successfully protected macaques from retroviral infection, mirroring the protection from HIV seen in CCR5 deficient individuals.

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            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable November 17, 2020

            Details:

            Leronlimab is an investigational humanized IgG4 mAb that blocks C-C chemokine receptor type 5. If successful, this Phase 2 trial could potentially allow leronlimab to be the first treatment for COVID-19 patients experiencing long-hauler syndrome.

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            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $28.5 million Upfront Cash: Undisclosed

            Deal Type: Financing November 11, 2020

            Details:

            The capital recieed from the proceed will enable CytoDyn to accelerate efforts to file BLAs in Canada and the U.K. for leronlimab as a combination therapy for HIV patients with one dose (one 350 mg subcutaneous injection) per week.

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            Lead Product(s): Leronlimab

            Therapeutic Area: Neurology Product Name: PRO 140

            Highest Development Status: Phase I Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2020

            Details:

            Company is accelerating the filing of a Ph2 protocol to evaluate leronlimab’s potential as a therapeutic for stroke recovery. Administration of leronlimab resulted in approx. 70-75% CCR5 receptor occupancy in the Brain.

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            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2020

            Details:

            The BLA filing included a treatment regimen of one injection per week of 350 mg of the Company’s product leronlimab, as contrasted to the dosage used in the Phase 3 clinical trial conducted in the U.S. for this indication of two consecutive injections of 175 mg per week.

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            Lead Product(s): Leronlimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: PRO 140

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 20, 2020

            Details:

            The DSMC had three recommendations: Stop the trial due to safety concerns; increase the sample size to maintain the power to achieve the primary endpoint; Continue the study as planned, with the protocol defined sample size and power to achieve the primary endpoint.